Updated HHS Pediatric Antiretroviral Treatment Guidelines Released
>Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral, Department of Health and Human Services. Updated March 1, 2016
The HHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children announces the release of the updated Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
For a complete preview of key updates to the guidelines, please see What's New in the Guidelines. Additions and revisions are also highlighted in yellow throughout the text and tables of the PDF version of the guidelines.
To view or download the guidelines, go to the Pediatric Guidelines section of AIDSinfo. Separate PDF files of the tables or recommendations can also be downloaded from the page.
Key changes made by the Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children (the Panel) to update the March 5, 2015, Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection are summarized below. Text and references have been updated throughout the document to include new data and publications where relevant. Minor changes and edits have been made to enhance clarity and facilitate use of the Guidelines. All new changes are highlighted.
Stribild label updated
U.S. Food and Drug Administration, March 2, 2016
Recently the STRIBILD® (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablet label was updated to include drug-drug interaction information with quetiapine and ledipasvir/sofosbuvir and to update section 12.2 with information on the effects on serum creatinine. The changes to the label are summarized below.
Initiation of STRIBILD in patients taking quetiapine:
Consider alternative antiretroviral therapy to avoid increases in quetiapine exposure. If coadministration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reactions. Refer to the quetiapine prescribing information for recommendations on adverse reaction monitoring.
Initiation of quetiapine in patients taking STRIBILD:
Refer to the quetiapine prescribing information for initial dosing and titration of quetiapine.
- The safety of increased tenofovir concentrations in the setting of HARVONI® (ledipasivir/sofosbuvir) and STRIBILD has not been established. Coadministration is not recommended.
Effects on Serum Creatinine
The effect of cobicistat on serum creatinine was investigated in a Phase 1 study in subjects with an eGFR of at least 80 mL per minute (N=18) and with an eGFR of 50 to 79 mL per minute (N=12). A statistically significant change of eGFRCG from baseline was observed after 7 days of treatment with cobicistat 150 mg among subjects with an eGFR of at least 80 mL per minute (-9.9 ± 13.1 mL/min) and subjects with an eGFR of 50 to 79 mL per minute (-11.9 ± 7.0 mL per minute). These decreases in eGFRCG were reversible after cobicistat was discontinued. The actual glomerular filtration rate, as determined by the clearance of probe drug iohexol, was not altered from baseline following treatment of cobicistat among subjects with an eGFR of at least 50 mL per minute, indicating cobicistat inhibits tubular secretion of creatinine, reflected as a reduction in eGFRCG, without affecting the actual glomerular filtration rate.
COMPLERA label updated
U.S. Food and Drug Administration, March 2, 2016
The COMPLERA (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) label was recently updated to expand the patient population for use to include pediatric patients from 12 to less than 18 years of age. Other revisions were made for consistency with the Edurant (rilpivirine) label.
The recommended dose of COMPLERA in patients 12 years of age and older and weighing at least 35 kg is one tablet taken orally once daily with food.
ODEFSEY fixed dose approved
U.S. Food and Drug Administration - March 1, 2016
On March 1, 2016 the FDA approved ODEFSEY (emtricitabine, rilpivirine, and tenofovir alafenamide), 200/25/25 mg fixed-dose combination tablet. OFEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY.
The approval is supported by a bioequivalence study demonstrating that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey is supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI- and INSTI-based regimens and virologically suppressed adults with mild-to-moderate renal impairment.
Half of Gay Black Men May Become Infected With HIV, CDC Says
New national report highlights groups most at risk for the AIDS-causing virus
TUESDAY, Feb. 23, 2016 (HealthDay News) -- If current HIV rates continue, about half of gay and bisexual black men in the United States will be diagnosed with the AIDS-causing virus in their lifetime, a new government analysis says.
Gay and bisexual Hispanic males -- another population group at serious risk of HIV -- have a one in four chance of contracting HIV, according to the report from the U.S. Centers for Disease Control and Prevention.
"As alarming as these lifetime risk estimates are, they are not a foregone conclusion. They are a call to action," said Dr. Jonathan Mermin, director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and Tuberculosis Prevention. "The prevention and care strategies we have at our disposal today provide a promising outlook for future reductions of HIV infections and disparities in the U.S., but hundreds of thousands of people will be diagnosed in their lifetime if we don't scale up efforts now."
The study found the overall risk of HIV in the United States has dropped to one in 99 over a lifetime, the CDC reported. That's down from one in 78 about 10 years ago. But certain minority groups continue to be hit hardest.
March 10th is Nation Woman and Girls HIV/AIDS Awareness Day
National Women and Girls HIV/AIDS Awareness Day (NWGHAAD) is an annual observance that sheds light on the impact of HIV and AIDS on women and girls. Every year on March 10, and throughout the month of March, federal, national, and community organizations come together to show support for women and girls impacted by HIV and AIDS. This year marks the 11th observance of National Women and Girls HIV/AIDS Awareness Day.
Today, about one in four people living with HIV in the United States is female. Only about half of women living with HIV are getting care, and only four in 10 of them have the virus under control.